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FDA 510(k)

AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30

K-Number: K001285 · 2000-06-02

ApplicantDiagnostic Chemicals , Ltd.
Decision Date2000-06-02
Product CodeJIF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 2000-06-02 under 510(k) number K001285. The device is classified under product code JIF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30?

AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 is a medical device that received FDA 510(k) clearance on 2000-06-02. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K001285.

When did AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 receive FDA 510(k) clearance?

AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 received FDA 510(k) clearance on 2000-06-02, under 510(k) number K001285.

Who is the listed applicant for AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30?

The FDA 510(k) record lists Diagnostic Chemicals , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30?

The FDA product code for AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 is JIF.

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Other records listing Diagnostic Chemicals , Ltd. as applicant

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K070383ENZYMATIC CREATININE ASSAY (265 SERIES)K063208MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7K060139CRP-ADVANCE ASSAY, MODELS 250-20, 250-25K060140CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250K051757CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91K051191DCL MICROALBUMIN ASSAY, MODEL 252-20

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Related Devices (Code: JIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183517Ammonia IIRoche Diagnostics Operations (Rdo)K123677DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)Siemens Healthcare DiagnosticsK123320DIMENSION AMMONIA FLEX REAGENT CARTRIDGESiemens Healthcare DiagnosticsK062316DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGEDade Behring, Inc.K051114SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAYSentinel Ch. SrlK033921AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10Diagnostic Chemicals , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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